OXCARBAZEPINA 300 mg Tabletka Powlekana

Treść ulotki

1. Oxcarbazepina TecniGen 300 mg tablets
2. Oxcarbazepina
   1. WHAT IS OXCARBAZEPINA TECNIGEN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING OXCARBAZEPINE TECNIGEN
   3. HOW TO TAKE OXCARBAZEPINE TECNIGEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE OXCARBAZEPINA TECNIGEN
   6. PACKAGE CONTENTS AND OTHER INFORMATION
3. Oxcarbazepine TecniGen 600 mg tablets
4. Oxcarbazepine
   1. WHAT IS OXCARBAZEPINA TECNIGEN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING OXCARBAZEPINE TECNIGEN
   3. HOW TO TAKE OXCARBAZEPINE TECNIGEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE OXCARBAZEPINA TECNIGEN
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Oxcarbazepina TecniGen 300 mg tablets

Generic medicine

Oxcarbazepina

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Oxcarbazepina TecniGen is and what it is used for.
• 2. What you need to know before you take Oxcarbazepina TecniGen.
• 3. How to take Oxcarbazepina TecniGen.
• 4. Possible side effects.
• 5. How to store Oxcarbazepina TecniGen.
• 6. Contents of the pack and other information.

1. WHAT IS OXCARBAZEPINA TECNIGEN AND WHAT IT IS USED FOR

What is Oxcarbazepina TecniGen
The active ingredient of Oxcarbazepina TecniGen is oxcarbazepine.
Oxcarbazepina TecniGen belongs to a group of medicines called anticonvulsants or antiepileptics.

What is Oxcarbazepina TecniGen used for
Medicines like Oxcarbazepina TecniGen are the standard treatment for epilepsy.
Patients to whom epilepsy is diagnosed have experienced seizures or convulsions. Seizures
occur due to a temporary defect in the brain's electrical system. The cells of the
brain normally coordinate body movements by sending outgoing signals to the muscles, in an
organized and orderly manner, through the nerves.
In epilepsy, the brain cells send too many outgoing signals in a disorganized manner. This can
lead to uncoordinated muscle activity defined as an epileptic seizure.
Oxcarbazepina TecniGen is used for the treatment of partial seizures with or without tonic-clonic
seizures with secondary generalization. Partial epileptic seizures involve a limited area
of the brain but can spread throughout the brain and cause generalized tonic-clonic
seizures. There are two types of partial epileptic seizures: simple and complex. During
simple partial seizures the patient remains conscious while in complex partial seizures
the patient's consciousness is altered.
Oxcarbazepina TecniGen, by keeping the brain's "hyperexcitable" nerve cells under control,
suppresses or reduces the frequency of these seizures.
Oxcarbazepina TecniGen can be used alone or in combination with other antiepileptic medicines.
Generally, the doctor will try to find the medicine that works best for you or for your child.
However, in more severe cases of epilepsy, it may be necessary to resort to a combination of two or more
medicines to control seizures.
The use of Oxcarbazepina TecniGen is reserved for adults and children aged 6 years and over.

2. WHAT YOU NEED TO KNOW BEFORE TAKING OXCARBAZEPINE TECNIGEN

Follow all the instructions your doctor has given you, even if they differ from the information contained in
this leaflet.

Do not take Oxcarbazepina TecniGen

• If you are allergicto oxcarbazepine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Oxcarbazepina TecniGen.

Talk to your doctor before taking Oxcarbazepina TecniGen if any of the following conditions apply to
you:

• if you have ever shown unusual sensitivity(skin rash or other signs of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the chances that you may also have an allergic reaction to oxcarbazepine are approximately 1 in 4 (25%);
• if you have a kidney disease;
• if you have severe liver disease;
• if you are taking diuretics(medicines used to help the kidneys eliminate salts and water by increasing the amount of urine produced);
• if you have heart problems, shortness of breath and/or swelling of the feet or legs due to fluid accumulation;
• if blood tests show that you have low levels of sodium in the blood(see section 4 Possible side effects);
• if you are a woman taking hormonal contraceptives, such as the pill, Oxcarbazepina TecniGen may block the action of the contraceptive. Use a different or additional (non-hormonal) method of contraception while taking Oxcarbazepina TecniGen. This helps to prevent unwanted pregnancy. Contact your doctor immediately if you experience bleeding or irregular vaginal discharge. If you have any questions about this, ask your doctor or healthcare professional.

If you develop any of the following symptoms after starting treatment with Oxcarbazepina TecniGen, contact
your doctor immediately or go to the nearest hospital emergency room:

• if you experience an allergic reactionafter starting treatment with Oxcarbazepina TecniGen. Symptoms include swelling of lips, eyelids, face, throat, mouth or sudden breathing problems, fever with swollen glands, skin rash or blisters on the skin;
• if you notice symptoms of hepatitis, such as jaundice (yellowing of the skin and whites of the eyes);
• if you experience an increase in the frequency of seizures. This is particularly important for children but can also occur in adults.
• if you notice possible symptoms of blood disorderssuch as fatigue, shortness of breath during physical activity, paleness, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, bleeding or bruising that develops more easily than normal, nosebleeds, reddish or purplish spots or blemishes on the skin of unknown cause;
• a reduced number of people treated with antiepileptic medicines like Oxcarbazepina TecniGen have had thoughts of suicide or self-harm. If, at any time, you have these thoughts,

contact your doctor immediately.

If you develop the following symptoms after starting treatment with Oxcarbazepina TecniGen, contact
your doctor as soon as possible:

• If your heartbeat is fast or unusually slow.

Children and adolescents
The doctor may recommend monitoring thyroid function before and during
treatment in children.

Other medicines and Oxcarbazepina TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This is especially important for:

• hormonal contraceptives, such as the pill (see Warnings and precautions);
• other antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin or lamotrigine;
• medicines that lower sodium levels in the blood, such as diuretics (used to help the kidneys eliminate salts and water by increasing the amount of urine produced), desmopressin and non-steroidal anti-inflammatory drugs, such as indometacin;
• lithium or monoamine oxidase inhibitors (medicines used to treat mood changes or some forms of depression);
• medicines that control the immune system, such as cyclosporine and tacrolimus.

Oxcarbazepina TecniGen with food, drinks and alcohol
Oxcarbazepina TecniGen can be taken with or without food.
Alcohol may increase the sedative effect of Oxcarbazepina TecniGen. Avoid drinking alcohol as much as possible
and ask your doctor for advice.

Pregnancy and breastfeeding
Pregnancy
Talk to your doctor if you are pregnant or planning to become pregnant.
It is important to control seizures during pregnancy. However, there may be a risk to
your baby if you take antiepileptic medicines during pregnancy. Your doctor will tell you about the benefits
and potential risks involved and help you decide whether to take Oxcarbazepina TecniGen.

Congenital defects
Studies have not shown an increased risk of congenital defects associated with the use of
oxcarbazepine during pregnancy, however, the risk of congenital defects for the unborn child cannot be completely excluded.
Neurological development disorders
Some studies have shown that exposure to oxcarbazepine in the womb negatively affects
brain function development (neurological development) in children, while other studies have not
found such an effect. The possibility of an effect on neurological development cannot be excluded
Do not stop treatment with Oxcarbazepina TecniGen during pregnancy without first
consulting your doctor.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Breastfeeding
If you are taking this medicine, ask your doctor for advice before starting to breastfeed. The
active ingredient of Oxcarbazepina TecniGen passes into breast milk. Although the available data
suggest that the amount of Oxcarbazepina TecniGen that passes to a breastfed baby is
low, the risk of side effects for the baby cannot be excluded.
Your doctor will discuss with you the benefits and potential risks of breastfeeding while taking
Oxcarbazepina TecniGen. If you are breastfeeding while taking Oxcarbazepina TecniGen and
believe your baby has side effects such as excessive sleepiness or poor weight gain,
inform your doctor immediately.

Driving and using machines
Oxcarbazepina TecniGen can cause drowsiness or dizziness.
It is important to consult your doctor about whether it is possible to drive vehicles or use machines
while taking this medicine.

3. HOW TO TAKE OXCARBAZEPINE TECNIGEN

Take this medicine always exactly as your doctor or pharmacist has told you, even if
it differs from what is stated in this leaflet. If you have any doubts, ask your doctor or pharmacist.

How much Oxcarbazepine TecniGen to take
Dose for adults

• The usual starting doseof Oxcarbazepine TecniGen for adults (including elderly patients) is 300 mg, twice a day.
• Your doctor may gradually increase the dose to find the best dose for you. The best results are generally obtained with doses between 600 and 2400 mg per day .
• If you are taking another antiepileptic medicine, the dose remains the same.
• If you have kidney disease (which impairs kidney function), the starting dose is half the usual starting dose.
• If you have severe liver disease, your doctor may adjust your dose.

Dose for children
Oxcarbazepine TecniGen can be taken by children aged 6 years and over.
The dosage in children depends on their weight.

• The starting dose is 8-10 mg per kg of body weight per day, administered in two separate doses. For example, a child weighing 30 kg should start treatment with half a 300 mg tablet, twice a day.
• Your doctor may gradually increase the dose to reach the best dose for your child. The best results are generally achieved with a dose of 30 mg per kg of body weight per day. The maximum dose for a child is 46 mg per kg of body weight per day.

How to take Oxcarbazepine TecniGen

• Swallow the tablets with a little water.
• If necessary, the tablets can be divided into two equal halves.
• For young children who cannot swallow tablets or who cannot be given the necessary dose in tablet form, oxcarbazepine is available as an oral suspension.

When and for how long to take Oxcarbazepine TecniGen
Take Oxcarbazepine TecniGen twice a day, every day, at about the same time of day, unless
your doctor has told you to do otherwise. This will have a better effect on controlling epilepsy and
will also help you remember when to take the tablet(s).
Your doctor will tell you how long your treatment with Oxcarbazepine TecniGen or your child’s treatment will last.
The duration of treatment will depend on the type of seizures you or your child have. To control
convulsive seizures, treatment may be necessary for many years. Do not change the dose or stop treatment without talking to your doctor.

If you take more Oxcarbazepine TecniGen than you should
If you have taken more tablets than prescribed by your doctor, contact your doctor or the nearest
hospital immediately. Symptoms of overdose with Oxcarbazepine TecniGen may
include: drowsiness, dizziness, feeling unwell (nausea), feeling sick (vomiting), increased
uncontrolled movements, lethargy, confusion, muscle contractions or significant worsening of
seizures, problems with coordination and/or involuntary eye movements.

If you forget to take Oxcarbazepine TecniGen
If you forget to take a dose, take it as soon as you remember. However, if it is time to
take the next dose, do not take the forgotten dose. Return to your normal dosing schedule.
Never take a double dose.
If you are not sure or have forgotten to take some doses, consult your doctor.

If you stop taking Oxcarbazepine TecniGen
Do not stop treatment with this medicine unless your doctor has told you to do so.
To prevent a sudden worsening of seizures, do not stop taking the medicine abruptly.
If you stop treatment, you must do so gradually following your doctor's instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects can occur with certain frequencies which are defined as follows:

• Very common: affects more than 1 in 10 people.
• Common: affects 1 to 10 in 100 people.
• Uncommon: affects 1 to 10 in 1,000 people.
• Very rare: affects less than 1 in 10,000 people.
• Not known: the frequency cannot be estimated from the available data.

Some side effects can be serious: seek immediate medical attention
The following are symptoms of very rare but potentially serious side effects that may require
urgent medical treatment.

• Swelling of lips, eyelids, face, throat or mouth accompanied by difficulty with breathing, speech or swallowing (signs of anaphylactic reactions and angioedema) or other signs of hypersensitivity reactions such as rash, fever and muscle and joint pain.
• Severe blistering of the skin and/or mucous membranes of lips, eyes, mouth, nasal cavities or genitals (signs of a severe allergic reaction including Lyell's syndrome, Stevens-Johnson syndrome and erythema multiforme). The risk of severe skin reactions associated with the use of carbamazepine or chemically related compounds in patients of Chinese Han ethnicity or Thai origin can be predicted by performing a test on a blood sample from these patients. The doctor should be able to advise you whether a blood test is necessary before taking oxcarbazepine.
• Fatigue, shortness of breath during activity, paleness, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nosebleeds, reddish or purplish spots or patches on the skin of unknown cause (signs of a reduced number of platelets or blood cells).
• Rash with red patches mainly on the face that may be accompanied by fatigue, fever, feeling unwell (nausea), loss of appetite (signs of systemic lupus erythematosus).
• Lethargy, confusion, muscle contractions or significant worsening of seizures (possible symptoms of a decrease in blood sodium levels) (see Warnings and precautions).
• Flu-like symptoms with jaundice (yellowing of the skin or whites of the eyes) (signs of hepatitis)
• Severe pain in the upper abdomen (stomach), feeling unwell (vomiting), loss of appetite (signs of inflammation of the pancreas).
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs of hypothyroidism).

Seek immediate medical attention or go to the nearest hospital emergency room if
you experience any of the above side effects.The doctor will also decide whether treatment with
Oxcarbazepina TecniGen should be stopped immediately and how to continue further care.

Other side effects: see a doctor as soon as possible
Common:

• tremor, coordination problems, involuntary eye movements, anxiety and nervousness, depression, rash. Very rare:
• irregular heartbeat or very fast or slow heartbeat. See a doctor as soon as possible if you experience any of the above side effects. They may require medical attention.

Other side effects: see a doctor if these effects worry you
These side effects due to Oxcarbazina TecniGen are generally mild to moderate. Many of
these effects are transient and generally decrease over time.

Very common:

• fatigue, headache, dizziness, drowsiness, feeling unwell (nausea), feeling sick (vomiting), double vision. Common:
• weakness, memory problems, impaired concentration, apathy, agitation, confusion, blurred vision, constipation, diarrhea, stomach (abdominal) pain, acne, hair loss, balance disorders. Uncommon:
• urticaria. It is possible that you may have increased liver enzyme values while taking Oxcarbazina TecniGen. Not known:
• high blood pressure.

See a doctor if any of the above side effects becomes severe.
Cases of bone diseases including osteopenia and osteoporosis (thinning of the bones) and
fractures have been reported. Contact your doctor or pharmacist if you are on long-term therapy with an antiepileptic medicine,
if you have a history of osteoporosis or are taking steroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OXCARBAZEPINA TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Oxcarbazepina TecniGen contains

• The active ingredient of Oxcarbazepina TecniGen is oxcarbazepine. Each tablet contains 300 mg of oxcarbazepine.
• The other ingredients are microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, colloidal silicon dioxide, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Oxcarbazepina TecniGen and package contents
Oxcarbazepina TecniGen 300 mg tablets are oblong tablets, bright pink in colour, with an
incision line on one side and a 3 embossed on the other side.
The tablets are available in blisters containing 50 tablets.

Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal.

Oxcarbazepine TecniGen 600 mg tablets

Generic medicine

Oxcarbazepine

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Oxcarbazepine TecniGen is and what it is used for.
• 2. What you need to know before you take Oxcarbazepine TecniGen.
• 3. How to take Oxcarbazepine TecniGen.
• 4. Possible side effects.
• 5. How to store Oxcarbazepine TecniGen.
• 6. Contents of the pack and other information.

1. WHAT IS OXCARBAZEPINA TECNIGEN AND WHAT IT IS USED FOR

What is Oxcarbazepina TecniGen
The active ingredient of Oxcarbazepina TecniGen is oxcarbazepine.
Oxcarbazepina TecniGen belongs to a group of medicines called anticonvulsants or antiepileptics.

What is Oxcarbazepina TecniGen used for
Medicines like Oxcarbazepina TecniGen are the standard treatment for epilepsy.
Patients to whom epilepsy is diagnosed have experienced seizures or convulsions. Seizures
occur due to a temporary defect in the electrical system of the brain. The cells of the
brain normally coordinate the body's movements by sending outgoing signals to the muscles, in an
organized and orderly manner, through the nerves.
In epilepsy, the brain cells send too many outgoing signals in a disorganized manner. This can
lead to uncoordinated muscle activity defined as an epileptic seizure.
Oxcarbazepina TecniGen is used for the treatment of partial seizures with or without tonic-clonic
seizures with secondary generalization. Partial epileptic seizures involve a limited area
of the brain but can spread throughout the brain and cause generalized tonic-clonic
seizures. There are two types of partial epileptic seizures: simple and complex. During
simple partial seizures the patient remains conscious while in complex partial seizures
the patient's consciousness is altered.
Oxcarbazepina TecniGen, by keeping under control the “hyperexcitable” nerve cells of the brain,
suppresses or reduces the frequency of these seizures.
Oxcarbazepina TecniGen can be used alone or in combination with other antiepileptic medicines.
Generally, the doctor will try to find the medicine that works best for you or for your child.
However, in more severe cases of epilepsy, it may be necessary to resort to a combination of two or more
medicines to control seizures.
The use of Oxcarbazepina TecniGen is reserved for adults and children aged 6 years and over.

2. WHAT YOU NEED TO KNOW BEFORE TAKING OXCARBAZEPINE TECNIGEN

Follow all the instructions your doctor has given you, even if they differ from the information contained in
this leaflet.

Do not take Oxcarbazepina TecniGen

• If you are allergicto oxcarbazepine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Oxcarbazepina TecniGen.

Talk to your doctor before taking Oxcarbazepina TecniGen if any of the following conditions apply to you:

• if you have ever shown unusual sensitivity(skin rash or other signs of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the chances that you may also have an allergic reaction to oxcarbazepine are approximately 1 in 4 (25%);
• if you have a kidney disease;
• if you have a severe liver disease;
• if you are taking diuretics(medicines used to help the kidneys eliminate salts and water by increasing the amount of urine produced);
• if you have heart problems, shortness of breath and/or swelling of the feet or legs due to fluid accumulation;
• if blood tests show that you have low levels of sodium in your blood(see section 4 Possible side effects);
• if you are a woman taking hormonal contraceptives, such as the pill, Oxcarbazepina TecniGen may block the action of the contraceptive. Use a different or additional (non-hormonal) method of contraception while taking Oxcarbazepina TecniGen. This helps to prevent unwanted pregnancy. Contact your doctor immediately if you experience bleeding or irregular vaginal discharge. If you have any questions about this, talk to your doctor or healthcare professional.

If you develop any of the following symptoms after starting treatment with Oxcarbazepina TecniGen, contact your doctor immediately or go to the nearest hospital emergency room:

• if you experience an allergic reactionafter starting treatment with Oxcarbazepina TecniGen. Symptoms include swelling of lips, eyelids, face, throat, mouth or sudden breathing problems, fever with swollen glands, skin rash or blisters on the skin;
• if you notice symptoms of hepatitis, such as jaundice (yellowing of the skin and whites of the eyes);
• if you experience an increase in the frequency of seizures. This is particularly important for children but can also occur in adults.
• if you notice possible symptoms of blood disorderssuch as fatigue, shortness of breath during physical activity, paleness, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, bleeding or bruising that develops more easily than usual, nosebleeds, reddish or purplish spots or patches on the skin of unknown cause;
• a reduced number of people treated with antiepileptic medicines like Oxcarbazepina

TecniGen have had thoughts of suicide or self-harm. If, at any time, you have these thoughts, contact your doctor immediately.

If you develop the following symptoms after starting treatment with Oxcarbazepina TecniGen, contact your doctor as soon as possible:

• If your heartbeat is fast or unusually slow.

Children and adolescents
In children, the doctor may recommend monitoring thyroid function before and during
treatment.

Other medicines and Oxcarbazepina TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This is especially important for:

• hormonal contraceptives, such as the pill (see Warnings and precautions);
• other antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin or lamotrigine;
• medicines that lower sodium levels in the blood, such as diuretics (used to help the kidneys eliminate salts and water by increasing the amount of urine produced), desmopressin and non-steroidal anti-inflammatory drugs, such as indometacin;
• lithium or monoamine oxidase inhibitors (medicines used to treat mood changes or some forms of depression);
• medicines that control the immune system, such as cyclosporine and tacrolimus.

Oxcarbazepina TecniGen with food, beverages and alcohol
Oxcarbazepina TecniGen can be taken with or without food.
Alcohol may increase the sedative effect of Oxcarbazepina TecniGen. Avoid drinking alcohol as much as possible and
ask your doctor for advice.

Pregnancy and breastfeeding
Pregnancy
Talk to your doctor if you are pregnant or planning to become pregnant.
It is important to control seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic medicines during pregnancy. Your doctor will tell you about the benefits and potential risks involved and will help you decide whether to take Oxcarbazepina TecniGen.

Congenital defects
Studies have not shown an increased risk of congenital defects associated with the use of
oxcarbazepine during pregnancy, however, the risk of congenital defects for the unborn child cannot be completely excluded.

Neurological developmental disorders
Some studies have shown that exposure to oxcarbazepine in the womb negatively affects
brain function development (neurological development) in children, while other studies have not
found such an effect. The possibility of an effect on neurological development cannot be excluded
Do not stop treatment with Oxcarbazepina TecniGen during pregnancy without first
consulting your doctor.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Breastfeeding
If you are taking this medicine, ask your doctor for advice before starting to breastfeed. The
active ingredient of Oxcarbazepina TecniGen passes into breast milk. Although the available data
suggest that the amount of Oxcarbazepina TecniGen that passes to a breastfed baby is
low, the risk of side effects for the baby cannot be excluded.
Your doctor will discuss with you the benefits and potential risks of breastfeeding while taking
Oxcarbazepina TecniGen. If you are breastfeeding while taking Oxcarbazepina TecniGen and
believe your baby has side effects such as excessive sleepiness or poor weight gain,
inform your doctor immediately.

Driving and using machines
Oxcarbazepina TecniGen can cause drowsiness or dizziness.
It is important to consult your doctor about whether it is possible to drive vehicles or use machines
while taking this medicine.

3. HOW TO TAKE OXCARBAZEPINE TECNIGEN

Take this medicine following the instructions of your doctor or pharmacist exactly, even if
they differ from what is stated in this leaflet. If you have any doubts, ask your doctor or pharmacist.

How much Oxcarbazepina TecniGen to take
Dose for adults

• The usual starting doseof Oxcarbazepina TecniGen for adults (including elderly patients) is 300 mg, twice a day.
• Your doctor may gradually increase the dose to find the best dose for you. The best results are generally obtained with doses between 600 and 2400 mg per day .
• If you are taking another antiepileptic medicine, the dose remains the same.
• If you have kidney disease (which impairs kidney function), the starting dose is half the usual starting dose.
• If you have severe liver disease, your doctor may adjust your dose.

Dose for children
Oxcarbazepina TecniGen can be taken by children aged 6 years and over.
The dosage in children depends on their weight.

• The starting dose is 8-10 mg per kg of body weight per day, administered in two separate doses. For example, a child weighing 30 kg should start treatment with half a 300 mg tablet, twice a day.
• Your doctor may gradually increase the dose to reach the best dose for your child. The best results are generally achieved with a dose of 30 mg per kg of body weight per day. The maximum dose for a child is 46 mg per kg of body weight per day.

How to take Oxcarbazepina TecniGen

• Swallow the tablets with a little water.
• If necessary, the tablets can be divided into two equal halves.
• For young children who cannot swallow tablets or who cannot be given the necessary dose in tablet form, oxcarbazepine is available as an oral suspension.

When and for how long to take Oxcarbazepina TecniGen
Take Oxcarbazepina TecniGen twice a day, every day, at about the same time of day, unless
your doctor has told you to do otherwise. This will have a better effect on controlling epilepsy and
will also help you remember when to take the tablet(s).
Your doctor will tell you how long your treatment with Oxcarbazepina TecniGen or your child’s treatment will last.
The duration of treatment will depend on the type of seizures you or your child have. To control
seizures, treatment may be necessary for many years. Do not change the dose or stop treatment without talking to your doctor.

If you take more Oxcarbazepina TecniGen than you should
If you have taken more tablets than prescribed by your doctor, contact your
doctor or the nearest hospital immediately. Symptoms of overdose with Oxcarbazepina TecniGen may
include: drowsiness, dizziness, feeling unwell (nausea), feeling sick (vomiting), increased
uncontrolled movements, lethargy, confusion, muscle contractions or significant worsening of
seizures, problems with coordination and/or involuntary eye movements.

If you forget to take Oxcarbazepina TecniGen
If you forget to take a dose, take it as soon as you remember. However, if it is time to
take the next dose, do not take the forgotten dose. Return to your normal dosing schedule.
Never take a double dose.
If you are not sure or have forgotten to take some doses, ask your doctor.

If you stop taking Oxcarbazepina TecniGen
Do not stop treatment with this medicine unless your doctor has told you to do so.
To prevent a sudden worsening of seizures, do not stop taking the medicine abruptly.
If you stop treatment, you must do so gradually following your doctor's instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These side effects can occur with certain frequencies which are defined as follows:

• Very common: affects more than 1 in 10 patients.
• Common: affects 1 to 10 patients in 100.
• Uncommon: affects 1 to 10 patients in 1,000.
• Very rare: affects less than 1 in 10,000 patients.
• Not known: the frequency cannot be estimated from the available data.

Some side effects can be serious: seek immediate medical attention
The following are symptoms of very rare but potentially serious side effects that may require
urgent medical treatment.

• Swelling of lips, eyelids, face, throat or mouth accompanied by difficulty breathing, speaking or swallowing (signs of anaphylactic reactions and angioedema) or other signs of hypersensitivity reactions such as rash, fever and muscle and joint pain.
• Severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal cavities or genitals (signs of a severe allergic reaction including Lyell's syndrome, Stevens-Johnson syndrome and erythema multiforme). The risk of severe skin reactions associated with the use of carbamazepine or chemically related compounds in patients of Chinese Han ethnicity or Thai origin can be predicted by testing a blood sample from these patients.

The doctor should be able to advise you if a blood test is necessary before
taking oxcarbazepine.

• Fatigue, shortness of breath during activity, paleness, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nosebleeds, reddish or purplish spots or blemishes on the skin of unknown cause (signs of a reduction in the number of platelets or blood cells).
• Rash with red spots mainly on the face which may be accompanied by fatigue, fever, feeling unwell (nausea), loss of appetite (signs of systemic lupus erythematosus).
• Lethargy, confusion, muscle contractions or significant worsening of seizures (possible symptoms of a decrease in blood sodium levels) (see Warnings and precautions).
• Flu-like symptoms with jaundice (yellowing of the skin or whites of the eyes) (signs of hepatitis).
• Severe pain in the upper abdomen (stomach), feeling unwell (vomiting), loss of appetite (signs of inflammation of the pancreas).
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs of hypothyroidism).

Seek immediate medical attention or go to the nearest hospital emergency room if
you experience any of the above side effects.The doctor will also decide whether treatment with
Oxcarbazepine TecniGen should be stopped immediately and how to continue further care.

Other side effects: see a doctor as soon as possible
Common:

• tremor, coordination problems, involuntary eye movements, anxiety and nervousness, depression, rash. Very rare:
• irregular heartbeat or a very fast or slow heartbeat. See a doctor as soon as possible if you experience any of the above side effects. They may require medical attention.

Other side effects: see a doctor if these effects worry you
These side effects due to Oxcarbazina TecniGen are generally mild to moderate. Many of
these effects are transient and generally decrease over time.

Very common:

• fatigue, headache, dizziness, drowsiness, feeling unwell (nausea), feeling sick (vomiting), double vision. Common:
• weakness, memory problems, impaired concentration, apathy, agitation, confusion, blurred vision, constipation, diarrhea, stomach (abdominal) pain, acne, hair loss, balance disorders. Uncommon:
• urticaria. It is possible that you may have increased liver enzyme levels while taking Oxcarbazina TecniGen. Not known:
• high blood pressure.

See a doctor if any of the above side effects become severe.
Cases of bone diseases including osteopenia and osteoporosis (thinning of the bones) and
fractures have been reported. Contact your doctor or pharmacist if you are undergoing long-term therapy with an antiepileptic medicine,
if you have a history of osteoporosis or are taking steroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OXCARBAZEPINA TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging box after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Oxcarbazepina TecniGen contains

• The active ingredient of Oxcarbazepina TecniGen is oxcarbazepine. Each tablet contains 600 mg of oxcarbazepine.
• The other ingredients are microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, colloidal silicon dioxide, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Oxcarbazepina TecniGen and package contents
Oxcarbazepina TecniGen 600 mg tablets are oblong tablets, bright pink in color, with an
incision line on one side and a 6 embossed on the other side.
The tablets are available in blisters containing 50 tablets.

Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal.